(June 30, 2017): In March 2016, the Centers for Disease Control and Prevention (CDC) published "CDC Guideline for Prescribing Opioids for Chronic Pain – United States, 2016" [1] in an effort to address the seemingly ever-increasing deaths that have been attributed to opioid-related overdose. A number of states have passed legislation or enacted regulatory provisions designed to better safeguard patients from abuse and the public from illegal diversion.
For instance, Indiana,[2] Ohio[3] and Kentucky,[4] have all taken action to better ensure that physicians, nurse practitioners and physician assistants with qualified to prescribe opioids do in a manner that will protect patients from abuse and the public from illegal diversion. Many of the requirements put in place by these states track one or more of the recommendations set out in the CDC’s March 2016 guideline. The State of Maryland is merely the latest jurisdiction to take action in this regard. This article examines the approach that the Maryland legislative has taken and discusses the collateral impact that opioid prescribing practices can have on a provider's license and financial health.
I. Purpose of Maryland's Legislation "The Prescriber Limits of 2017":
On May 25, 2017, Maryland Governor Larry Hogan, signed-off on "The Prescriber Limits of 2017". The legislation was enacted as an emergency measure and was found to be needed for the immediate preservation of the public’s health and safety. As an emergency measure, it was passed by a “yea” and “nay” vote supported by three-fifths of all the members elected to the each of the two Houses of the General Assembly.
The statute's requirements are codified in several sections of the Code of Maryland, Article - Health Occupations. Several amendments were made to Section 1-223. As the Preamble to the legislation notes:
"The rise in overdose deaths is attributable to the surge of opioid dependence that has emerged in Maryland over the past two decades, stemming from a dramatic increase in the number of opioid medications prescribed by the medical community and the influx of cheap, potent heroin and fentanyl
II. Guidelines a Health Care Provider Must Follow When Prescribing an Opioid for Pain:
As set out under Section 1-223(B), a Maryland health care provider must base pain treatment decisions based on his / her clinical judgement. The health care provider must prescribe:
(1) The lowest effective dose of an opioid, and
(2) a quantity that is no greater than the quantity needed for the expected duration of pain severe enough to require an opioid that is a controlled dangerous substance unless the opioid is prescribed to treat:[5]
A substance-related disorder;
Pain associated with a cancer diagnosis;
Pain experienced while the patient is receiving end-of-life, hospice or palliative care services; or
Chronic pain.Section 1-223(c) requires that the dosage, quantity and duration of an opioid prescribed under Section 1-223(B) SHALL “be based on evidence-based clinical guideline for prescribing controlled substances that is appropriate” for:
(1) The health care service delivery setting for the patient;
The type of health care services required by the patient; and
The age and health status of the patient."
As Section 1-223(D) notes, if a prescribing health care provider violates one of the requirements set out under Section 1-223(B), the violation constitutes grounds for disciplinary action and the responsible Maryland Health Occupational Board[6] can take action against a licensee.
The prescriber is required to carefully document in the patient's medical record the reasons(s) why a drug other than an opiate was not appropriate in the care and treatment of a particular patient. Additionally, the prescriber must document that the patient is receiving palliative care or that the decision is based on the prescriber's professional judgment that the exemption is reasonable and appropriate.
An interesting component of the law’s requirement is that a prescriber is required, if requested by a patient, the patient’s legal representative or guardian, to issue an opioid prescription for a lesser amount that the prescriber initially intended to prescribe. The prescriber must also document in the patient’s medical records that such a request was made and who made it.
III. Maryland Licensing Boards are Authorized to Discipline Physicians, Nurse Practitioners, Physician Assistants, Podiatrists and Dentists Who Violate “The Prescriber Limits of 2017.”
As the Preamble to the legislation notes, state licensing boards play an important role in the education and supervision of licensees under their jurisdiction who prescribe opioids and other controlled substances. It was the intent of the General Assembly that the:
". . . State Board of Dental Examiners, State Board of Nursing, State Board of Physicians, and State Board of Podiatric Medical Examiners shall work to educate practitioners to ensure that the residents of Maryland are aware of the risks associated with the use of opioid drugs, including the risks of dependence, addiction, and overdose, and the dangers of taking an opioid drug with alcohol, benzodiazepines, and other depressants;"
Amendments to the Authority of the Maryland Board of Dentistry.
The amendments made to Section 4-315(a) modified the list of reasons that the Board may “deny a general license to practice dentistry, a limited license to practice dentistry, or a teacher’s license to practice dentistry to any applicant, reprimand any licensed dentist, place any licensed dentist on probation, or suspend or revoke the license of any licensed dentist.” Under the legislation, these actions may now also be taken if an applicant or licensed dentist:
.....
(33) Fails to comply with any Board order; [or]
(34) Willfully and without legal justification, fails to cooperate with a lawful investigation conducted by the Board; OR
(35) Fails to comply with § 1-223 of this Article.
Amendments to the Authority of the Maryland Board of Nursing.
The amendments made to Section 8-316(a) modified the list of reasons that the Board may “deny a license or grant a license, including a license subject to a reprimand, probation, or suspension, to any applicant, reprimand any licensee, place any licensee on probation, or suspend or revoke the license of a licensee. .". Under the legislation, these actions may now also be taken if an applicant or licensed nurse:
(34) When acting in a supervisory position, directs another nurse to delegate a nursing task to an individual when that nurse reasonably believes:
.....
(ii) The patient’s condition does not allow delegation of the nursing task; [or]</br />
(35) Has misappropriated the property of a patient or a facility; OR</br />
(36) Fails to comply with the opioid prescribing limitation established under §1–223 of this article.
Amendments to the Authority of the Maryland Board of Medicine.
Consistent with the amendments made to Section 14-404(a), subject to the hearing provisions of §14-405 of this subtitle:
. . .a disciplinary panel, on the affirmative vote of a majority of the quorum of the disciplinary panel, may reprimand any licensee, place any licensee on probation, or suspend or revoke a license if the licensee:
(41) Performs a cosmetic surgical procedure in an office or a facility that is not:
(ii) Certified to participate in the Medicare program, as enacted by Title XVIII of the Social Security Act; [or]
(42) Fails to submit to a criminal history records check under § 14–308.1 of this title; OR
(43) Fails to comply with the opioid prescribing limitation established under § 1–223 of this article.
Amendments to the Authority of the Maryland Board of Podiatric Medical Examiners.
Amendments were made to Section 16-313 to bring provisions governing applicants and licensed podiatrists into alignment with the requirements of "The Prescriber Limits of 2017." Amendments made include:
Subject to the hearing provisions of § 16–313 of this subtitle, the Board, on the affirmative vote of a majority of its members then serving, may deny a license or a limited license to any applicant, reprimand any licensee or holder of a limited license, impose an administrative monetary penalty not exceeding $50,000 on any licensee or holder of a limited license, place any licensee or holder of a limited license on probation, or suspend or revoke a license or a limited license if the applicant, licensee, or holder:
(8) Prescribes or distributes a controlled dangerous substance to any other person in violation of the law, including in violation under §1–223 of this article;
IV. Conclusion:
Physicians, nurse practitioners and physician assistants authorized to prescribe opioids and other controlled substances, need to review both the CDC guidance and any state requirements that have been issued to protect both patients and the public from abuse and diversion. Prescriptions for opioids are continuously monitored by a variety of law enforcement agencies and government program integrity contractors. In addition to the Drug Enforcement Agency[10] (DEA), your prescribing and billing practices are actively being assessed by Medicare, Medicaid and private payor auditors and investigators. You should monitor and audit your practices as part of your overall Compliance Program. To the extent that your prescribing and / or billing practices are different from those of your peers, there is a significant likelihood in today’s enforcement environment that you will be audited.
Should you receive an audit request from a ZPIC or UPIC, we strongly recommend that you contract a qualified health lawyer to advise you regarding the records submission and appeals process. This initial level of the audit is a provider’s best opportunity to present his / her arguments in support of payment in a positive light.
- [1] Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep. 2016;65:1-49. http://dx.doi.org/10.15585/mmwr.rr6501e1.
- [2] A copy of Senate Enrolled Act No. 226 (SEA 226), amended the Indiana Code and established "Chapter 9.7. Prescribing and Dispensing Opioids." A copy of the legislation can be found at: https://iga.in.gov/legislative/2017/bills/senate/226#document-b9523207
- [3]State of Ohio, Board of Pharmacy. "FAQ: New Limits on Prescription Opiates for Acute Pain, Updated 4/3/2017." http://www.pharmacy.ohio.gov/Documents/Pubs/Special/ControlledSubstances/New%20Limits%20on%20Prescription%20Opiates%20for%20Acute%20Pain%20-%20Frequently%20Asked%20Questions.pdf
- [4] See Kentucky House Bill 333 http://www.lrc.ky.gov/recorddocuments/bill/17RS/HB333/bill.pdf
- [5] Although Maryland’s statute does not provide dosage recommendations, prescribers may wish to consider the recommendations made by the CDC in its March 2016 guidance. As Recommendation #6 provides:
Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed. - [6] The State Board of Dental Examiners, State Board of Nursing, State Board of Physicians, and State Board of Podiatric Medical Examiners.
- [7] HHS OIG. "High Part D Spending on Opioids and Substantial Growth in Compounded Drugs Raise Concerns" (OEI-02-16-00290)(Page 4). 6/21/2016. https://oig.hhs.gov/oei/reports/oei-02-16-00290.pdf
- [8] Lembke A, Chen J. Use of Opioid Agonist Therapy for Medicare Patients in 2013. JAMA Psychiatry. 2016; 73(9): 990-992.
- [9] Ghate SR, Haroutiunian S, Winslow R, McAdam-Marx C. Cost and comorbidities associated with opioid abuse in managed care and Medicaid patients in the United States: a comparison of two recently published studies. Journal of Pain & Palliative Care Pharmacotherapy. 2010 Sep; 24(3): 251-8.
- [10] DEA is an agency of the U.S. Department of Justice. A link to the agency’s diversion program description is: https://www.deadiversion.usdoj.gov/